Neuralink can now study its brain implant in humans, but it’s still catching up to its peers
May 26, 2023... Neuralink, however closely watched, is still catching up to its peers in the neurotechnology field.
Science finally figured out how to make effective RSV vaccines. Will seniors care?
May 26, 2023... A host of hurdles threaten to hinder the use of newly developed RSV vaccines for older adults.
Will Medicare cover it? Drugs like Aduhelm are challenging its standard
May 25, 2023... Medicare’s coverage decision has revived longstanding questions about how the federal program determines whether it will pay for new drugs and devices.
We’ll soon have tools to protect infants against RSV. Can we put them to good use?
May 24, 2023... Medical professionals who care for kids are ecstatic they may soon have tools to prevent RSV. They are also aware of the challenges ahead.
Achieve Life Sciences drug helps smokers quit in trial but would face stiff competition if approved
May 23, 2023... In a trial, Achieve's cytisinicline helped smokers quit without major side effects. But if approved it would face stiff competition from varenicline.
Three ways to test medical AI for safety
May 23, 2023... The biggest challenge of using generative AI in medicine is the hallucination problem, in which the system just makes things up.
FDA advisers vote against approving Intercept’s NASH drug
May 19, 2023... A panel of expert advisers to the FDA voted against approving Intercept Pharmaceuticals’ investigational treatment for NASH, a prevalent liver disease with no available medicines.
Pharmalittle: AstraZeneca plans to ‘love’ China’s Communist Party; U.S. Supreme Court rules against Amgen in patent case
May 19, 2023... The U.S. Supreme Court upheld a ruling that Amgen failed to disclose sufficient information about patent claims for its cholesterol drug Repatha.
FDA advisory panel backs Pfizer’s RSV vaccine, but expresses some safety concerns
May 18, 2023... A committee of vaccine experts voted to recommend the FDA approve Pfizer’s maternal RSV vaccine, though some members expressed safety concerns.
Pharmalittle: Appellate judges appear skeptical of FDA decisions on abortion pill; FTC widens probe into PBMs
May 18, 2023... A federal appeals court panel heard arguments in a case that could determine the future of a commonly used abortion pill.
In Belgium, a native son returns to resurrect the drugmaker Galapagos — and ‘to get the trust back’
May 18, 2023... There is, according to Wall Street, no worse investment in biotech than Galapagos NV. But a new team is seeking to mount a turnaround.
Federal judges question FDA authority in abortion pill hearing
May 17, 2023... Federal judges questioned the FDA's authority during an appeals court hearing over the agency's approval of the abortion pill mifepristone.
Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective
May 17, 2023... The FTC's suit to block Amgen from acquiring Horizon Therapeutics cast a spotlight on a practice known as bundling.
Pfizer RSV vaccine seen as effective against severe disease, FDA documents say
May 16, 2023... An experimental RSV vaccine developed by Pfizer to protect infants — by vaccinating pregnant people — was shown to be effective in preventing severe lower respiratory tract disease, the FDA said.
The U.S. needs to pressure India to improve drug safety
May 16, 2023... The situation will only improve under international pressure from countries that are importing drugs from India.
Pharmalittle: FDA OKs new kind of drug to treat hot flashes; Alzheimer’s drug could cost Medicare up to $5 billion a year
May 15, 2023... The FDA approved a new kind of drug to treat hot flashes, which could offer relief to women who do not want to take hormone therapy.
FDA advisory panel narrowly recommends approval for Sarepta’s gene therapy for Duchenne
May 12, 2023... A panel of independent advisers to the FDA narrowly voted 8 to 6 to recommend accelerated approval for Sarepta’s gene therapy for Duchenne muscular dystrophy.
Sponsored Insight
Cardiopulmonary risk in COPD patients: The case for early and proactive treatment to prevent premature death
May 12, 2023... Chronic obstructive pulmonary disease (COPD) is a serious chronic respiratory condition — more specifically, a group of conditions, including emphysema and chronic bronchitis — that affects hundreds of millions of people worldwide, often causing poor quality of life, hospitalizations, and even death.1,2 For too many patients, COPD exacerbations, which are the acute worsening of symptoms…
Pharmalittle: U.S. Senate committee passes PBM bills; Pfizer CEO predicts pharma will sue over Medicare price negotiations
May 12, 2023... The U.S. Senate health committee passed a package of bills aimed at speeding generic drug competition and reining in pharmacy benefit managers.
Tracking the FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy
May 12, 2023... We're live-blogging today's FDA advisory panel on Sarepta’s gene therapy for Duchenne muscular dystrophy.
An ultrasound device may unlock brain cancer treatment, early study shows
May 12, 2023... It's difficult for chemotherapy treatments to cross the blood-brain barrier. In a small study, a new implantable ultrasound device shows promise in doing so.
A former health insurance executive turns to tech to make claims less of a nightmare
May 11, 2023... Former Elevance executive Rajeev Ronanki has taken over as CEO at Lyric, where he wants to transform the confusing world of insurance claims with tech.
Pharmalittle: FDA panel recommends first OTC birth control pill; Senate hearing on insulin costs satisfies no one
May 11, 2023... An advisory panel of independent experts voted unanimously that the FDA should approve the first over-the-counter birth control pill.
How the FDA’s pandemic flexibilities boosted mental health apps — and what happens now
May 11, 2023... The FDA's pandemic flexibilities gave a major boost to mental health apps. What happens now?
Lawmakers press CMS to release new breakthrough device coverage rule
May 10, 2023... Lawmakers echoed device makers' call for an easier pathway to CMS reimbursement of medical device breakthroughs at a congressional hearing Wednesday.
Pharmalittle: Gilead wins lawsuit against HHS over HIV pill patents; most Americans say abortion pill should remain on the market
May 10, 2023... Gilead Sciences prevailed in a closely watched battle with the U.S. government over the rights to groundbreaking HIV prevention pills.
FDA reviewers had string of concerns about Sarepta’s gene therapy for Duchenne, documents show
May 10, 2023... Reviewers at the FDA concluded that Sarepta Therapeutics did not show that its gene therapy for Duchenne muscular dystrophy will likely benefit patients and left key safety concerns.
What FDA mandate? Sun Pharma halts shipments from a plant with a troubled history
May 9, 2023... The FDA has found that a Sun Pharmaceuticals facility in India failed to comply with a legal mandate to correct serious shortcomings.
4 ways the health care system should shift its thinking on AI, according to experts
May 5, 2023... “People are thinking of ChatGPT as like a box. The progress in the field has not been this box,” one expert said at #STATBreakthrough. It's all the technology inside it.